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Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments

Primary Purpose

Colon Cancer Screening, Colon Polyps, Colon Adenomas

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Olympus transparent cap
Medivators Endocuff
Control
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colon Cancer Screening focused on measuring distal colonoscope attachments, colon cancer screening, screening colonoscopy, adenoma detection

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 50 years old
  • Presenting for a screening or surveillance colonoscopy at UC Davis Endoscopy Suites

Exclusion Criteria:

  • Age less than 50 years
  • Prior history of colon cancer
  • Patients with inflammatory bowel disease
  • Patients suspected to have colon cancer based on non invasive tests such as stool tests for hemoglobin or DNA, or imaging finding suggestive of colon cancer (CT or barium enema).
  • Patients undergoing colonoscopy for evaluation of symptoms such as abdominal pain, rectal bleeding, diarrhea, constipation, etc, or patient with iron deficiency anemia suspected to be due to ongoing bleeding inside the colon
  • Patients with family history of colon cancer in 1st degree relative below the age of 60
  • Patients with family history of hereditary polyposis syndromes such as Lynch syndrome, familial adenomatous polyposis etc, which are associated with an increased risk of colon cancer
  • Patients unable to consent
  • Pregnant patients
  • Incarcerated patients
  • Non-English speakers

Sites / Locations

  • University of California, Davis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

Control

Olympus transparent cap

Medivators Endocuff

Arm Description

Standard colonoscopy - no distal colonoscope attachment will be used in this arm

The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure

The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure

Outcomes

Primary Outcome Measures

Adenoma Detection Rate
The investigators will compare adenoma detection rate at completion of study across the 3 arms

Secondary Outcome Measures

Proximal Adenoma Detection Rate
The investigators will compare proximal adenoma detection rate at completion of study across the 3 arms
Cecal Intubation Rate
The investigators will compare cecal intubation rate at completion of study across the 3 arms
Withdrawal Time
The investigators will compare colonoscopy withdrawal time rate at completion of study across the 3 arms

Full Information

First Posted
January 25, 2016
Last Updated
June 4, 2020
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT02665741
Brief Title
Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments
Official Title
Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this study is to compare two FDA approved distal colonoscope attachment devices, in order to identify which device can increase adenoma detection rate the most without increasing procedure time or risk.
Detailed Description
Although mortality from colon cancer is decreasing, it remains the second leading cause of cancer related death in the United States. There are multiple factors contributing to this decrease, such as increased awareness, improving screening techniques, etc. Of the available modalities approved for colon cancer screening in the United States, colonoscopy is considered the gold standard. Colonoscopy has the advantage of being both diagnostic and therapeutic, allowing the removal of pre-cancerous polyps, before the polyps can transform into cancer. Colonic polyps can occur at any location from the rectum to the cecum. Colonoscopy has been shown to be more effective in decreasing incidence of cancer in the left colon but remains limited in the detection of right sided polyps /lesions 2. This difference based on location is thought to be due to several reasons. Typically the right side of the colon is less clean than the left side during colonoscopy, thereby impairing visualization of polyps. This problem has been overcome by incorporating a "split bowel preparation", which has not become standard of care. However, the problem of not being able to visualize polyps behind folds seen in the colon persists despite improvements in the quality of cleansing of the colon. Various endoscopic technologies have been introduced with the goal of assisting with the manipulation of such colonic folds, and thereby reducing chances of missing polyps behind fold. Two such colonoscope assisted devices including the distal transparent cap and the Endocuff endoscopic overtube. The Endocuff overtube is a small device with flexible arms arranged in 2 rows. Each row has 8 short, soft arms projecting away from the device. These arms are used to peel back the colonic folds without causing physical damage to enable visualization behind colonic folds. The use of Endocuff overtube has shown promising results in terms of cecal intubation rate and time as well as adenoma detection rates 3. The transparent cap attachment is a clear plastic device that fits at the end of the colonoscope and extends a short distance past the tip of the colonoscope. It aids in the manipulation of folds and in maintaining a suitable distance from the mucosa, with the goal of improving visualization. Although some studies comparing cap fitted colonoscopy to standard (non- attachment) colonoscopies have shown improved adenoma detection 4, others have shown no significant benefit 5. Although, these devices have been compared with conventional colonoscopies (i.e without any distal attachment), to the investigator's knowledge, there are currently no studies that have compared these two distal colonoscope attachment devices head-to-head, and none has specifically evaluated effects on detection of right sided adenomas. Also, here at UCDavis, these devices are being used specifically in diagnostic colonoscopies for removal of large polyps and the choice of which specific device is used depends on level of comfort of the advanced endoscopist. The endoscopists participating in the investigators' study do not currently use these devices as part of their routine colonoscopies, thus it is important to provide head to head comparison of these devices to help guide management practice. Therefore, the investigators' goal is to compare the Endocuff overtube assisted, transparent cap fitted, and non-cap fitted (standard) colonoscopy in patients presenting to UC Davis Medical Center for screening colonoscopies. In addition, 2 of the 3 investigators will employ the water exchange method during for all arms of the trial, while the other investigator will employ the conventional air method of colonoscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer Screening, Colon Polyps, Colon Adenomas, Water Exchange Colonoscopy
Keywords
distal colonoscope attachments, colon cancer screening, screening colonoscopy, adenoma detection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
Standard colonoscopy - no distal colonoscope attachment will be used in this arm
Arm Title
Olympus transparent cap
Arm Type
Experimental
Arm Description
The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure
Arm Title
Medivators Endocuff
Arm Type
Experimental
Arm Description
The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure
Intervention Type
Device
Intervention Name(s)
Olympus transparent cap
Intervention Description
distal colonoscope attachment
Intervention Type
Device
Intervention Name(s)
Medivators Endocuff
Intervention Description
distal colonoscope attachment
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
No distal colonoscope attachments
Primary Outcome Measure Information:
Title
Adenoma Detection Rate
Description
The investigators will compare adenoma detection rate at completion of study across the 3 arms
Time Frame
Completion of procedure
Secondary Outcome Measure Information:
Title
Proximal Adenoma Detection Rate
Description
The investigators will compare proximal adenoma detection rate at completion of study across the 3 arms
Time Frame
Completion of procedure
Title
Cecal Intubation Rate
Description
The investigators will compare cecal intubation rate at completion of study across the 3 arms
Time Frame
Completion of procedure
Title
Withdrawal Time
Description
The investigators will compare colonoscopy withdrawal time rate at completion of study across the 3 arms
Time Frame
Completion of procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 50 years old Presenting for a screening or surveillance colonoscopy at UC Davis Endoscopy Suites Exclusion Criteria: Age less than 50 years Prior history of colon cancer Patients with inflammatory bowel disease Patients suspected to have colon cancer based on non invasive tests such as stool tests for hemoglobin or DNA, or imaging finding suggestive of colon cancer (CT or barium enema). Patients undergoing colonoscopy for evaluation of symptoms such as abdominal pain, rectal bleeding, diarrhea, constipation, etc, or patient with iron deficiency anemia suspected to be due to ongoing bleeding inside the colon Patients with family history of colon cancer in 1st degree relative below the age of 60 Patients with family history of hereditary polyposis syndromes such as Lynch syndrome, familial adenomatous polyposis etc, which are associated with an increased risk of colon cancer Patients unable to consent Pregnant patients Incarcerated patients Non-English speakers
Facility Information:
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
20042716
Citation
Brenner H, Hoffmeister M, Arndt V, Stegmaier C, Altenhofen L, Haug U. Protection from right- and left-sided colorectal neoplasms after colonoscopy: population-based study. J Natl Cancer Inst. 2010 Jan 20;102(2):89-95. doi: 10.1093/jnci/djp436. Epub 2009 Dec 30.
Results Reference
background
PubMed Identifier
25861907
Citation
Pioche M, Matsumoto M, Takamaru H, Sakamoto T, Nakajima T, Matsuda T, Abe S, Kakugawa Y, Otake Y, Saito Y. Endocuff-assisted colonoscopy increases polyp detection rate: a simulated randomized study involving an anatomic colorectal model and 32 international endoscopists. Surg Endosc. 2016 Jan;30(1):288-95. doi: 10.1007/s00464-015-4208-8. Epub 2015 Apr 11.
Results Reference
background
PubMed Identifier
22228167
Citation
Westwood DA, Alexakis N, Connor SJ. Transparent cap-assisted colonoscopy versus standard adult colonoscopy: a systematic review and meta-analysis. Dis Colon Rectum. 2012 Feb;55(2):218-25. doi: 10.1097/DCR.0b013e31823461ef.
Results Reference
background
PubMed Identifier
19251004
Citation
Harada Y, Hirasawa D, Fujita N, Noda Y, Kobayashi G, Ishida K, Yonechi M, Ito K, Suzuki T, Sugawara T, Horaguchi J, Takasawa O, Obana T, Oohira T, Onochi K, Kanno Y, Kuroha M, Iwai W. Impact of a transparent hood on the performance of total colonoscopy: a randomized controlled trial. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):637-44. doi: 10.1016/j.gie.2008.08.029.
Results Reference
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Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments

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